Patient safety is at the heart of all quality systems in the pharmaceutical industry. Ensuring patient safety, in turn, requires adherence to quality standards that can vary from country to country. The global supply chain in today’s pharmaceutical industry requires quality standards that can ensure patient safety for many different countries simultaneously. Pharmacopoeias set the minimal quality standards for medicinal products in many global regions.
The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) collaborates with global pharmacopoeia to develop and promote scientifically valid public standards that ensure patient safety and encourage harmonization of requirements among regions. IPEC-Americas consists of members representing excipient manufacturers, users, and distributors that all share a common goal of collaborating with pharmacopoeia to enhance patient safety.
Between April 2020 and May 2022, IPEC-Americas provided 37 formal comment letters to USP, EDQM,1 and PMDA2 (combined). Proactive monitoring of compendial postings enabled timely review of new and revised monographs and general chapters, as well as general chapter prospectus and USP stimuli articles. As an example, IPEC-Americas provided general recommendations for development of USP General Chapter <1083> Supplier Qualification when the general chapter prospectus was posted. By the time that the proposed general chapter was posted in PF47(5), additional stakeholder input had been gathered and specific recommendations for supplier qualification by compounding pharmacies were provided. IPEC-Americas has shared articles published in pharmaceutical trade journals that contain compendial references. Members have also notified USP of IPEC-Americas’ intention to revise IPEC guides, which are the basis of several USP general chapters. Unsolicited comments have been submitted offering technical subject matter expertise on the impact of advanced analytical techniques.
IPEC-Americas, as a pharmacopeial stakeholder, has submitted comments on emerging trends (e.g., control of contaminants in hand sanitizer, nitrosamine impurities, and excipient composition), to encourage harmonization among pharmacopoeia, and to recognize the efforts of the pharmacopoeia to continually advance compendial content.
IPEC-Americas members develop and attend webinars on global quality standards for excipients presented by SMEs and attend webinars/workshops sponsored by major pharmacopoeias (e.g., USP and EDQM). Historically, these forums have covered regulatory requirements in major world markets and issues that affect excipients use (e.g., nitrosamines, ingredients in hand sanitizers, and proposed regulations to treat certain excipients as microplastics). Recent USP webinars, workshops, and open forums promoted and attended by IPEC-Americas members covered such topics as The Future of Public Commenting, Modernization of USP Amino Acid Monographs, and the USP Prescription/Non- Prescription Stakeholder Forum. IPEC-Americas often hosts a debrief session following these workshops and forums to determine whether additional follow-up with the USP or other organization may be of value.
IPEC-Americas members have unique opportunities to work with many advanced SMEs and to contribute comments to proposals in the various pharmacopoeia. The topics are often complex and beyond the scope of individual companies, limiting the ability to individually comment and influence standard development. Working in collaboration with other IPEC-Americas members adds a wealth of information, which often exceeds that of individual organizations.
An example is the development of the new Elemental Impurities general chapters in the USP and Ph. Eur. based on ICH Q3D. This topic was very complex with major impact to excipient manufacturers and users. IPEC-Americas led the creation of The Coalition for Rational Implementation of Elemental Impurities. This coalition included other organizations such as CHPA,3 NJPQCA,4 and SOCMA.5 Over the course of nearly four years, the coalition successfully worked with the USP and Ph. Eur. to align the language of the USP and Ph. Eur. general chapters with ICH. Due to the leadership provided by IPEC-Americas and involvement from other pharmaceutical organizations, the coalition successfully addressed many industry concerns. This resulted in good alignment between the USP and Ph. Eur. general chapters with ICH Q3D.
In conclusion, participation in IPEC-Americas compendial postings review and commenting activities offers members opportunities to influence global pharmacopoeia on topics of importance to the manufacture and use of excipients. Working in collaboration with other IPEC-Americas members and other organizations, individuals gain knowledge beneficial to their career growth, their employers and the pharmaceutical industry. IPEC-Americas members have an opportunity to make significant contributions to the development of compendial standards that help ensure the quality of excipients and, ultimately, the safety of drug products utilized by patients.
References
1. European Directorate for the Quality of Medicines & Healthcare
2. Japan Pharmaceutical and Medical Device Agency
3. Consumer Healthcare Products Association
4. New Jersey Pharmaceutical Quality Control Association
5. Society of Chemical Manufacturers and Affiliates